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Medtronic survey says pandemic has negatively impacted those with chronic back, leg pain

Medtronic (NYSE:MDT) today released data from a survey demonstrating several struggles for those with chronic pain during the COVID-19 pandemic.

The survey, commissioned by Medtronic and conducted by public opinion research firm The Harris Poll, found that 44% of current chronic back and leg pain sufferers experienced care delays during the COVID-19 pandemic despite 87% reporting that their pain has not improved — or has even worsened — since the pandemic began two years ago in March 2020.

A total of 810 U.S. adults who experience chronic back or leg pain participated in the survey, which found far-reaching impacts of the condition on patient lifestyle, everyday activities and mental state. Those impacts were further exacerbated by the pandemic’s impact on stressed health systems nad the ability of patients to seek timely care, according to a news release.

More than half (52%) of the survey takers who reported worsening chronic pain during the pand…

Vaxxas licenses COVID-19 vaccine for patch delivery system, expects to finish Phase 1 trial this year

Vaxxas’ patch comes in a hockey-puck-shaped applicator with a foil seal. [Image courtesy of Vaxxas]Vaxxas announced today that it was granted an exclusive license to a next-generation COVID-19 vaccine for use with its delivery patch.

Cambridge, Massachusetts-based Vaxxas received the exclusive license from The University of Texas at Austin for its HexaPro SARS-CoV-2 spike subunit vaccine.

Get the full story at our sister site, Drug Delivery Business News.

Moderna seeks FDA blessing for second COVID-19 vaccine booster

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine.

Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older.

In its submission, Moderna included data gathered from the U.S. and Israel after the emergence of the omicron variant.

Data on the efficacy of a fourth dose of Moderna’s vaccine against omicron were recently published in NEJM. The researchers, considering data from the Moderna and Pfizer-BioNTech vaccines, concluded that a fourth dose of mRNA vaccine appears to be “immunogenic, safe, and somewhat efficacious (primarily against symptomatic disease).”

In January, early data from Israel’s Sheba Medical Center indicated that an additional booster of COVID-19 vaccine from Pfizer and BioNTech drove to a fivefold increase in antibodi…

Moderna says its mRNA Access program could help with the next pandemic

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases.

“It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships.

“mRNA Access was born of the idea that we are stewards of our platform, and by allowing researchers to access that platform, and leverage the preclinical, clinical, regulatory and manufacturing capabilities that we’ve created, we could accelerate the development of novel vaccines,” Bennett said.

To prepare for future pandemics, the company is keeping tabs on known and emerging pathogens that pose a considerable risk with the potential for devastating impact on lives around the globe.

Before the pandemic, Moderna had mRNA de…

Engineered yeast could be a key for more affordable COVID-19 vaccines

A new protein subunit vaccine developed at MIT and Beth Israel Deaconess Medical Center may offer an inexpensive, easy-to-store, and effective alternative to RNA vaccines for Covid-19. Pictured is a schematic of the vaccine.

Researchers at MIT and Beth Israel Deaconess Medical Center are exploring a yeast-based alternative to RNA vaccines.

A new paper highlights a vaccine, which comprises fragments of the SARS-CoV-2 spike protein arrayed on a virus-like particle, that reportedly elicited a strong immune response and protected animals against viral challenge, according to a post on MIT’s website.

Get the full story at our sister site, Pharmaceutical Processing World.

Engineered yeast could be a key for more affordable COVID-19 vaccines

A new protein subunit vaccine developed at MIT and Beth Israel Deaconess Medical Center may offer an inexpensive, easy-to-store, and effective alternative to RNA vaccines for Covid-19. Pictured is a schematic of the vaccine.[Image from Jose-Luis Olivares, MIT, and figures courtesy of the researchers]

Researchers at MIT and Beth Israel Deaconess Medical Center are exploring a yeast-based alternative to RNA vaccines.

A new paper highlights a vaccine, which comprises fragments of the SARS-CoV-2 spike protein arrayed on a virus-like particle, that reportedly elicited a strong immune response and protected animals against viral challenge, according to a post on MIT’s website.

The researchers designed the vaccine to be produced by yeast, using fermentation facilities that already exist around the world. MIT said the Serum Institute of India — the world’s largest vaccine manufacturer — is now prod…

Roche says its research-only COVID-19 tests can detect a range of variants, subvariants

Roche announced today that its TIB Molbiol subsidiary has made available testing solutions that can identify a number of COVID-19 variants.

Basel, Switzerland-based Roche’s testing offerings can identify the SARS-CoV-2 (the virus causing COVID-19) B.1.1.529 variant and differentiate between the omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and delta, according to a news release.

VirSNiP SARS-CoV-2 Spike S371L S373P and VirSNiP SARS-CoV-2 Spike S371L S373P 452R are Roche’s research use-only tests now available, adding to the test kits previously developed by Roche and TIB Molbiol for detecting recent BA.1 and BA.2, as well as other mutations, present in the novel B.1.1.529 omicron SARS-CoV-2 variant.

The company said TIB Molbiol’s researchers work in collaboration with academic contacts to continually screen for new variants and emerging diseases.

“Roche is pleased to offer testing options addressing the ongoing COVID-19 he…

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

Get the full story on our sister site Drug Discovery & Development.

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

One dataset involved patient records from the Israeli Ministry of Health involving more than 1.1 million adults at least 60 years old with no known prior COVID-19 infection eligible for a fourth dose booster. That data suggested that individuals receiving an additional dose were half as likely to be infected and had one-fourth the risk of contracting severe illness than those who had received a single booster.

The companies also submitted data from an ongoing, open-label, non-randomized study focused on healthcare w…

Valneva anticipates EMA nod for its COVID-19 vaccine candidate in April

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate.

The firm announced on February 25 that CHMP had sent the company a series of questions as part of its initial assessment, to which it responded within two working days.

It anticipates that it can swiftly respond to the latest batch of questions.

Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022.

In such a case, the company would supply European countries with the vaccine in the second quarter of the year.

Valneva has an agreement with the European Commission to provide up to 60 million doses of the vaccine over two years.

The company says t…

Pfizer-BioNTech vaccine moderately effective against omicron in children

The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study.

The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates.

Participants in the study received two doses of the vaccine.

The Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study incorporated real-world data and also gauged vaccine effectiveness against the delta variant.

Studying weekly nasal swab and survey data from 1,346 children in Arizona, Florida, Texas and Utah, researchers were able to capture mild infections.

“Other pediatric vaccine effectiveness studies relied on lab testing data or health records and generally captured only cases where a child had symptoms and received health care,” said Lauren Olsho, the PROTECT study’s principal investi…

NIH to study allergic reactions to COVID-19 mRNA vaccine

Image courtesy of Pexels

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

Get the full story at our sister site, Drug Discovery & Development.